The U.S. Food and Drug Administration recently warned that a common gout prescription may increase your chances of death from heart-related issues.
The drug is Uloric (also known as febuxostat), which is commonly prescribed to treat gout. The FDA study concluded that Uloric has an increased risk of cardiovascular death when compared to another gout medicine, allopurinol. As a result of the study, the FDA mandated that all Uloric prescriptions include a “Boxed Warning”—the FDA’s most prominent warning—about the risks of death. Physicians and pharmacists must also give patients a Medication Guide that outlines the risks in writing when prescribing the drug.
Additionally, the FDA is now limiting its approval rating for Uloric. After this study, the FDA will only approve the prescription of Uloric if the patient did not receive effective treatment from allopurinol, or if the patient suffered severe side effects from allopurinol. Based on the results of this new study, the FDA is also warning doctors and health care professionals to only prescribe Uloric for those patients who have failed treatment under allopurinol, or those patients who cannot tolerate it. Effectively, the FDA is mandating that Uloric be only a backup plan because of the drug’s increased risk of death.
Uloric’s History and Gout.
Uloric was first approved by the FDA back in 2009 as a prescription medicine to treat gout in adults. A form of arthritis, gout occurs when uric acid (which is a substance that is naturally present in the body) builds up. This build-up of uric acid can cause swelling, redness and pain in the body’s joints. Uloric was found to be effective in lowing uric acid levels in a person’s blood, mitigating the occurrence and effects of gout.
According to the FDA, citing a National Health and Nutrition Examination Survey, gout affects about 8.3 million adults in the United States. Gout is categorized as a chronic disease, and treatment can be difficult. There are very limited prescription options for treating gout, and, according to the FDA, the means for treating this disease are unmet by currently available options.
The Study and its Findings.
When Uloric was approved in 2009, the FDA included a warning about its potential negative impact on cardiovascular health. In its “Warning and Precaution” about Uloric published alongside the drug’s approval, the FDA highlighted that a serious side effect of the drug was possible cardiovascular events, such as heart attack and stroke.
Therefore, upon the drug’s approval, the FDA also mandated that the drug’s manufacturer, Takeda Pharmaceuticals, conduct a large safety clinical trial to explore the risks of cardiovascular death from the drug. The resulting clinical trial examined more than 6,000 patients who were either taking Uloric or the alternative drug, allopurinol, to treat their gout. The results show that patients taking Uloric had an increased risk of heart-related death, as well as risk of death from all causes. The study noted patient outcomes including heart attacks, stroke, heart-related death, and unstable angina, a condition caused by insufficient blood flow to the heart.
What Should You Do If You Suffer from Gout?
If you are an adult who has been diagnosed with gout, be aware of the risk of death from the drug Uloric. Speak with your physician or health care professional about your prescription choice, particularly if you have a history of stroke or heart issues. However, if you are currently taking Uloric, the FDA warns that you should not stop without first talking to your doctor; cutting off your medication can worsen your gout.
If you are currently taking Uloric, be aware of signals of cardiovascular problems, such as irregular heartbeat, dizziness, chest pain, shortness of breath, numbness on one side of your body, rapid heartbeat or a sudden severe headache. If you experience any of these symptoms, seek emergency medical attention right away.
Fournier’s Gangrene Tied to Diabetes Medications
Multiple cases of Fournier’s gangrene have been tied to diabetes medications. This condition is serious and can even be fatal. However, it is a rare condition which usually happens to men past middle age. In fact, lawsuits are being filed for the victims.
What is Fournier’s Gangrene?
Also known as necrotizing fasciitis, it affects the genital area – mainly of men. The condition is a bacterial infection that is found in the tissues under the part of the skin which is surrounding the blood vessels, fat, muscles and nerves of genitalia.
The most common people to suffer from this condition is males between the ages of 50 and 79. Only about 1.6 of 100,000 are diagnosed each year. It’s known as flesh-eating bacteria because that is what it does.
Fournier’s gangrene or genital gangrene as it’s often referred to develops when bacteria gets into the system from a tear or cut in the skin. It will spread quickly and destroys any tissue it comes into contact with. People who have diabetes are already more susceptible to gangrene because of a lower immunity system and reduced blood flow.
The Link Between Diabetes and Fournier’s Gangrene
In August of 2018, the Food and Drug Administration (FDA) provided a warning that people who were taking type 2 diabetes drugs were at an increased risk for developing this type of gangrene. The type of drugs, which are known as SGLT2 inhibitors will carry new warnings. The drugs included are:
And any generic versions.
These drugs work to lower blood sugar levels. They take away any extra glucose in the system by moving it through the kidneys and out of the body in urine. While the medications are designed for people who have been diagnosed with type 2 diabetes, they have shown to be helpful with those who have type 1 diabetes as well.
While the natural incidence rate is low, the number of people diagnosed between March 2013 and May 2018 was significantly higher with 12 cases. All were taking SGLT2 inhibitors. Five of the cases were female and seven were male. The patients were between the ages of 38 and 78 years of age. Fournier’s gangrene is rarely diagnosed in women.
According to reports, the patients developed the condition at an average of about 9 months after they began taking the medication. The actual development was from just seven days all the way to 25 months.
All of the cases required surgery for treatment with one needing skin graft surgery. All needed the infected tissue removed and five had multiple surgeries to take care of the condition. Out of the 12, four of the patients had complications from the condition. These complications included kidney injury, diabetic ketoacidosis and septic shock. One of the patients died. Two others had to go to a rehabilitation hospital.
Data was looked at for other patients who took alternative medications to reduce their blood sugar. During the period between 1984 and 2018, only six cases of the disease were diagnosed. All of the cases were men.
Treatment of the Condition
If a person is taking one of these SGLT2 inhibitors, they should pay attention if they notice swelling, redness or even tenderness of the genital area. If they have a temperature above 100.4 degrees Fahrenheit, they should seek medical attention right away. The condition can worsen quickly.
If the patient is diagnosed with Fournier’s gangrene, they will be treated with antibiotics and may need surgery. They should stop taking the diabetes medications but still monitor blood sugar levels.
The FDA has asked people who experience these or other side effects while taking the inhibitor to contact them and provide information about their case. The agency now requires a warning be included in medicine guides for patients and other information for medical personnel. It was estimated that 1.7 million patients received prescriptions for one of these drugs in 2017.
While genital gangrene has garnered attention with the SGLT2 inhibitors, this is not the only condition to be linked with the medication. Diabetic ketoacidosis is another disease which may be caused by taking the medication. It is another life-threatening condition, which requires treatment right away.
Since diabetics are more susceptible to many health conditions, experts say it is imperative that doctors are aware of these risks and educate patients on them. They need to provide information about recognizing and treating the conditions and advise them of the risk so the patient can make an informed decision about whether to take the medication.
The Diabetes Drug and Gangrene Scare
August 2018 the Food and Drug Administration alerted diabetic patients of the dangers of the SGLT2 inhibitor medications for a specific type of gangrene. This is not just one drug but a class of medications. The condition, commonly called genital gangrene, is serious and can even be fatal.
This type of drug is used to treat type 2 diabetes, but it has also seen some effectiveness in type 1 diabetes. Type 2 diabetes results in a high blood glucose level because the body cannot use the insulin up. It’s most common in middle-aged adults and seniors, but it can occur in other ages as well. This type of diabetes is known as hyperglycemia and is the most common form.
SGLT2 inhibitors work by moving the excess insulin out of the body through the kidneys and in the urine. They work in conjunction with diet and exercise to help the person be able to regulate their glucose levels.
Medications are used to control the diabetes unless the condition is too severe and requires other treatments. Since diabetes drugs are the most common form of treatment, it’s important for patients to understand the risks.
Gangrene and Diabetes
The type of gangrene the FDA warns of with the SGLT2 inhibitors is called Fournier’s gangrene or genital gangrene and is necrotizing fasciitis. It is a rare form of gangrene that only affects the genital areas of patients, mostly men.
In fact, most of the people diagnosed with this condition have been males between 50 and 70 years of age. It affects 1.6 men out of 100,000 each year, which shows how rare it is even for diabetics. A total of 1.7 million people received prescriptions for SGLT2 inhibitors in 2017.
To develop this condition, bacteria must enter a cut in the body. The bacteria then attack the tissue under the skin around the genital area. It causes an infection in the tissue and swelling or tenderness and redness around the genitals. If left untreated, it can cause a severe infection and loss of tissue as well as death.
The Link Between Genital Gangrene and Diabetes Medications
Studies indicate that taking the SGLT2 inhibitors can increase the risk for developing this condition. Between 2013 and 2018, 12 people were diagnosed with the condition, five of which were women. It’s extremely rare for a woman to develop this type of gangrene and at double the normal rate.
Anyone with diabetes is at a greater risk for developing gangrene than someone who doesn’t have the condition because of limited circulation and reduced blood flow. With the addition of the medication, the risk goes up even more.
The drug increases the amount of glucose in the urine, which helps to feed any infection in the body. It can slow down the healing process even if the cut is small. This allows the bacteria to continue to grow and develop into a serious situation.
Supporters of the medications say that 12 cases indicate a minimal risk for those who rely on the drugs to help them control their glucose levels. However, the FDA now requires manufacturers of these drugs to label them with the new warning. This ensures that they are aware of the risk if they choose to take the medication.
Of those 12 who were diagnosed with Fournier’s gangrene, one person died. Four others suffered various complications from the condition and all needed multiple surgeries to remove the dead tissue.
While genital gangrene is certainly one of the most serious results of taking these SGLT2 inhibitors, it is by no means the only risk. Anytime a medication causes additional glucose to move through the kidneys and urine, it puts the person at risk for other infections, such as urinary tract infections. Because diabetics heal at a slower rate in many cases, they can develop other complications and have a more severe reaction to the symptoms.
Anyone who is taking SGLT2 inhibitors should talk to their doctors about the risks and potential side effects. They not only need to know about genital gangrene but other conditions. They need to ask their doctor what symptoms to look for and what to do if they notice signs of problems.
While these inhibitors have shown some positive results for diabetics who are trying to control their type 2 diabetes, they do not come without some level of risk. Many patients may be able to take the drugs with no concerns, but they need to be aware of those risks and make an informed choice.
Heavy Painkillers Prescribed for Osteoarthritis—Despite High Risk of Falling
A recent study highlights that a major US health system has been prescribing strong opiods to treat osteoarthritis, despite a known risk of these drugs increasing the risk of dangerous falls.
Medical guidelines have consistently warned that treatment of osteoarthritis with opioids and benzodiazepines can increase a patient’s risk of falling. Despite this warning, however, physicians across one of the largest health systems in the US prescribed opioids for this condition nearly one-third of the time. Oftentimes, these prescriptions were to the particularly vulnerable elderly patient population.
The study tracked more than 20,000 osteoarthritis patients in the Atrium Health system, which serves patients across North Carolina and South Carolina. Every patient in the study had at least a primary diagnosis of osteoarthritis. After surveying the patients, the researchers found that these patients received a prescription for opioids and/or benzodiazepines in 32% of their visits. Hydrocodone was prescribed in almost half of the total visits. One-third of these prescriptions were early prescriptions and were therefore considered to be given to at risk patients.
Additionally, the research found that 3% of patients studied received both opioid and benzodiazepine prescriptions concurrently, despite significant evidence that taking these drugs together can be deadly.
These drugs are particularly dangerous for older patients, who are at a higher risk for falls and adverse medical reactions. Despite this risk, 43% of the patients studied were older than age 65.
Other studies have also shown that patients who receive opioids for their osteoarthritis have a more difficult time if they later undergo a total joint replacement surgery. These risks include a longer hospital stay, a harder time managing post-operation pain, and an increased chance of additional, revisionary procedures.
In fact, the American Association of Hip and Knee Surgeons recently warned that opioids should be avoided for the treatment of osteoarthritis in the hip and knee. The position states that these heavy drugs should be reserved for only the most exceptional of circumstances. That’s because patients can develop a tolerance of the drugs, and there is a high risk of dependence and abuse. Moreover, these doctors argue that opioids does not treat the underlying problem faced by these patients because osteoarthritis is a chronic disease.
Awareness of the opioid epidemic has increased over the last few months, with both public opinion and governmental policy highlighting the crisis. This study suggests that the medical community should explore new pathways for pain management in order to help curb the use of opioids for pain management in osteoarthritis.
Patient advocacy groups assert that primary care physicians and orthopedic surgeons should take the lead role in educating their patients on the risks of opioids. The risks discussed should include both the risk of tolerance and dependence, as well as the risk of falls, injury and fractures in the more vulnerable elderly patients. But this study highlights that despite having other, less risky pain management options available, physicians are prescribing these powerful drugs at an alarming rate.
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